False Claims Act Insights - Are All Healthcare “Kickbacks” Subject to FCA Liability?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 204: Accelerating Life Sciences Startups with James Chappell of SCbio
Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 203: Manufacturing Specialty Drugs for Rare Diseases in North Carolina with Paul Testa of Kyowa Kirin
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 201: SHL Medical’s Investment in the Carolinas with Kimberlee Steele of SHL Medical
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 195: Life Sciences and Healthcare Workforce Development with Dr. John Hauser of Gaston College
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 194: Workforce Development for the Life Sciences Industry with David Stefanich of Rymedi
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Changes in FDA, Cannabis Policies and AI Developments
340B Drug Pricing Program Compliance
Episode 185: America’s Bioeconomy with Sarah Glaven, White House Research Biologist
Episode 183: Site Development for Life Sciences Companies with Adam Bruns of Site Selection Magazine
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 171: Laura Gunter, President of the NC Life Sciences Organization
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 169: Shirley Paddock, Senior VP of Clinical Development, Syneos Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 168: Christine Harhaj, Senior Director of Advocacy & Strategic Alliances, PhRMA
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 165: Doug Edgeton, President and CEO of the North Carolina Biotechnology Center
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 163: David Ellison, Chief Data Scientist for Lenovo’s Infrastructure Solutions Group
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
In the last week, seven adalimumab biosimilars referencing HUMIRA entered the U.S. market: Boehringer Ingelheim’s CYLTEZO (adalimumab-adbm); Sandoz’s HYRIMOZ (adalimumab-adaz); Organon and Samsung Bioepis’s HADLIMA...more
Our readers may recall that nine HUMIRA biosimilars have been licensed to launch in July 2023, with Amgen’s AMJEVITA the only one to launch to date....more
On June 16, 2023, Coherus BioSciences, Inc. and Surface Oncology, Inc. announced that they have entered into a definitive merger agreement, where, at the closing, Coherus will acquire Surface Oncology, a clinical-stage...more
On March 6, 2023, Coherus Biosciences announced FDA approval of an autoinjectable version of Udenyca, Coherus’ biosimilar to Amgen’s Neulasta (pegfilgrastim). Udenyca (pegfilgrastim-cbqv) was first launched in the US in...more
On Jan 9, Coherus BioSciences, Inc. (“Coherus”) announced that it has agreed to acquire the exclusive commercialization rights to FYB203, a biosimilar referencing EYLEA (aflibercept) from Klinge Biopharma GmbH (“Klinge...more
Cimerli™ (ranibizumab-eqrn) was FDA approved on August 2, 2022 as interchangeable with Lucentis® (ranibizumab). Cimerli is the third interchangeable biosimilar approved in the US, following Semglee® (insulin glargine-yfgn),...more
On August 2, 2022, Coherus BioSciences, Inc. announced that the FDA approved CIMERLI™ (ranibizumab-eqrn) as a biosimilar interchangeable with LUCENTIS® (ranibizumab injection) for all five indications, with 12 months...more
Below are some highlights from first quarter 2022 earnings reports recently released by biologics and biosimilars companies: Biogen: Last week, Biogen reported total quarterly revenues of $2,532 million, and biosimilar...more
Today, Coherus BioSciences, Inc. announced that the FDA approved YUSIMRY (adalimumab-aqvh), a biosimilar of AbbVie’s HUMIRA product. YUSIMRY is indicated for plaque psoriasis, psoriatic arthritis, rheumatoid arthritis,...more
Last week, Coherus and Junshi Biosciences announced that the FDA accepted their BLA for toripalimab in combination with gemcitabine and cisplatin for the first-line treatment of patients with advanced recurrent or metastatic...more
On October 22, 2021 Roche announced the FDA’s approval of its ranibizumab intravitreal injection, marketed as Susvimo. Susvimo is a refillable ocular implant - requiring refills every six months - that continuously delivers...more
On October 1, 2021, Coherus BioSciences announced that FDA has accepted for review Coherus’ BLA for CHS-201, a candidate biosimilar to Lucentis® (ranibizumab), which is indicated for neovascular age-related macular...more
On February 15, 2021, Celltrion Healthcare announced that the European Commission granted marketing authorization for Yuflyma™ (CT-P17), an adalimumab biosimilar, on February 11, 2021. Yuflyma™ was approved across all...more
Mylan announced on its most recent quarterly earnings call that it expects to launch its rituximab and etanercept biosimilars in Europe later this year. In discussing Mylan’s biosimilars pipeline, Rajiv Malik, Mylan’s...more
As we previously reported, on February 11, 2020, Amgen sued Pfizer and its affiliate Hospira, alleging that their proposed biosimilar of Amgen’s NEULASTA (pegfilgrastim) would infringe U.S. Patent No. 8,273,707 (“the ’707...more
Multiple biosimilar developers recently released statements regarding potential regulatory delays facing their biosimilars or follow-on biologics. ...more
Regeneron’s EYLEA (aflibercept) was approved by the U.S. FDA on November 18, 2011, and is indicated for the treatment of patients with Neovascular (Wet) Age-related Macular Degeneration (AMD), Macular Edema following Retinal...more
Below are some recent developments in the biosimilar industry from around the globe: On January 14, 2020, Alvotech announced that it entered into a partnership with Canada-based JAMP Pharma for the supply and...more
As we start the new year, we look back at the top U.S. biosimilar market developments of 2019. Here are some of our highlights, in no particular order...more
As we previously reported, earlier this year Coherus filed a complaint against Amgen in the District of Delaware alleging infringement of patents claiming “stable aqueous pharmaceutical compositions” comprising adalimumab and...more
On December 6, 2019, the Federal Circuit will hear oral argument in a rituximab-related appeal by Biogen. The appeal stems from a final written decision of the Patent Trial and Appeal Board (PTAB) in an inter partes review...more
Here are some recent developments in U.S. legal proceedings relating to biosimilars: On December 10, 2018, in the Southern District of Florida, Apotex filed a motion to dismiss the patent infringement complaint that Amgen...more
Coherus announced today that it has executed settlement agreements with AbbVie that grant Coherus global, non-exclusive, royalty-bearing license rights under AbbVie’s intellectual property to commercialize CHS-1420, Coherus’...more
Coherus Biosciences announced today that it has entered into a $75 million senior secured credit facility agreement with Healthcare Royalty Partners. According to the press release, the funds will be used to “accelerate and...more
Here are our picks of some legal developments to keep an eye out for in the new year: 1. Etanercept biosimilar trial decision – This past September, in the Immunex v. Sandoz BPCIA patent litigation concerning Sandoz’s...more